BLOGSCAN - Direct-to-Consumer Device Advertising on YouTube Sans Adverse Effects Information

On the PostScript blog, the Prescription Project announced the discovery of direct-to-consumer marketing videos released on YouTube by three device companies. The video from Abbott advertised the XIENCE-V drug eluting stent. That from Medtronic advertised the Prestige cervical disc. That from Stryker advertised its Cormet hip resurfacing technology. Apparently none of these brave new advertisements bothered to put in the discussion about adverse effects mandated by the US Food and Drug Administration (FDA). The new media obviously presents new opportunities for marketing, including marketing that gets around rules usually applied in other media. Kudos to the Prescription Project for blowing the whistle on this one.

According to this post, soon after the three companies pulled these ads. The issue of new media DTC advertising produced quite a bit of internet buzz. Amazingly, among those agreeing with the Prescription Project's position was none other than Mr Peter Pitts of the DrugWonks blog, the Center for Medicine in the Public Interest, and the Manning, Selvage and Lee public relations firm.

Post Title → BLOGSCAN - Direct-to-Consumer Device Advertising on YouTube Sans Adverse Effects Information

BLOGSCAN - FDA Hires Pharmaceutical Marketing Agency to Educate Consumers About Drug Advertising

On the GoozNews blog, Merrill Goozner posted about how the US Food and Drug Administration (FDA) set up a program to educate consumers about direct-to-consumer (DTC) advertising. It seems that the organization the FDA hired for this purpose is nominally a not-for-profit, but not registered as such with the federal government, and is run by the president of a pharmaceutical marketing agency. The not-for-profit was funded mainly by the marketing agency, and its leadership all have connections with pharma. Sometimes, you just can't make this stuff up.

Meanwhile, on the PostScript blog, this post assessed the content of the web-site provided by this program. The site is, shall we say, not terribly skeptical about how the pharmaceutical industry advertises drugs. But what did we expect, given who provided the content?

Post Title → BLOGSCAN - FDA Hires Pharmaceutical Marketing Agency to Educate Consumers About Drug Advertising

The Rower Mis-Impresses? - Pfizer Ends its Lipitor Advertising Campaign

We posted last week about misleading aspects of the Pfizer Inc US television advertising campaign for Lipitor (atorvastatin), some of which were recently discovered by NY Times reporter Stephanie Saul. The ads centered on Dr Robert Jarvik. They touted him as a physician with great expertise about the heart. However, although Dr Jarvik does have an MD, he never was an intern or resident, never got a medical license, and never practiced medicine. Dr Jarvik's career is that of an inventor and biomedical engineer. Furthermore, the ads gave the impression that Dr Jarvik is tremendously fit, showing him jogging and apparently rowing a racing scull. However, a body double, not Dr Jarvik, was rowing the boat.

This week, Pfizer cancelled the advertising campaign. As reported again in the NY Times by Ms Saul, "Under criticism that its ads are misleading, Pfizer said Monday it would cancel a long-running advertising campaign using the artificial heart pioneer Dr. Robert Jarvik as a spokesman for its cholesterol drug Lipitor."

Meanwhile, further information came out suggesting that the campaign was even more misleading than previously thought. The ads originally touted Dr Jarvik as the inventor of the artificial heart. However, this is actually in dispute. Ms Saul also reported that

at least one former colleague of Dr. Jarvik’s ... contends that he was not the actual inventor of the artificial heart, as stated in the ads.

In a letter to Pfizer in August 2006, three former colleagues of Dr. Jarvik’s at the University of Utah complained that the ads erroneously identified Dr. Jarvik as 'inventor of the artificial heart.' That distinction, they said, should go to Dr. Jarvik’s mentor, Dr. Willem J. Kolff, and his associate, Dr. Tetsuzo Akutsu.

Pfizer subsequently changed its ads to identify Dr. Jarvik as the inventor of the 'Jarvik artificial heart,' but Dr. Jarvik’s former colleagues, members of a large team that worked on the heart, were not entirely satisfied, according to Dr. Donald B. Olsen, a veterinarian who worked on the heart and is president of the Utah Artificial Heart Institute.

In addition, the ads present Dr Jarvik as someone who actually takes Lipitor. However, Dr Jarvik really is not a long-term user of Lipitor. A NY Times editorial stated "that Dr. Jarvik only started taking Lipitor about a month after he started touting its virtues under a contract that would pay him a minimum of $1.35 million over two years."

Pfizer's decision to stop the advertisements drew praise from some US Congressmen who are now investigating direct to consumer (DTC) drug advertising. Bart Stupak (D - Michigan) said, "I commend Pfizer for doing the right thing and pulling the Lipitor ads featuring Dr Jarvik. When consumers see and hear a doctor endorsing a medication, they expect the doctor is a credible individual with requisite knowledge of the drug."

I agree that it is good that this particular advertising campaign has stopped. However, it is not clear whether the leadership of Pfizer, or of any pharmaceutical company has learned anything from this case. Here is how Pfizer explained its actions (again, per the NY Times article by Ms Saul),

'The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to mis-impressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world — cardiovascular disease,' Pfizer’s president of worldwide pharmaceutical operations, Ian Read, said in a statement. 'We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople.'

First, note that Mr Read's pledge of clarity seems limited only to "the presentation of spokespeople." Second, and more importantly, note that Mr Read, and through him, Pfizer really never admitted any fault, particularly not for fielding an advertising campaign that had multiple misleading elements. Instead, he seemed to spread the blame among television viewers and print media readers, that is, those who developed "mis-impressions and distractions." Note that Mr Read did not even admit that the advertisements were meant to market Lipitor. Instead, he portrayed them as an educational exercise meant to encourage "patient and physician dialogue."

It may be that it is hard for Pfizer leadership to move on from a two-year plus advertising campaign orchestrated by the Kaplan Thaler Group ((a unit of the Publicis Groupe) that cost more than $258 million since the beginning of 2006 (again per the Times article).

In my humble opinion, though, this inability to admit any fallibility on the part of Pfizer leadership underscores a central problem affecting the leadership of many health care organizations. Much current business thinking seems to support the concept of the infallibility and omniscience of "imperial CEOs," presumably partly to justify their pay so enormous it could not be due to mere mortal men and women. The infallible, by definition, do not make mistakes. So many organizations seem unable to admit mistakes, much less worse misconduct, by their leaders. Of course, inability to admit mistakes makes it likely that even worse mistakes will be made in the future.

The NY Times editorial called this case "a telling reminder that consumers, besieged by drug promotion ads on television and in print media, need to take what they see, hear and read with a very large grain of skepticism." It also suggested "drug companies would be wise to find pitchmen who have the credentials - and the athletic skill - to back up their claims, without having to rely on stunt doubles."

I say, as long as drug companies continue to be lead by "imperial CEOs," and hence by people insulated from criticism and immune to self-doubt, their emphasis on marketing ahead of science will continue. Furthermore, as long as drug company marketers are convinced that they are providing education, they will continue to make misleading pitches, no matter who the pitchmen are.

Post Title → The Rower Mis-Impresses? - Pfizer Ends its Lipitor Advertising Campaign

Rowing Aground - More on Dr Jarvik's Misleading Advertisements

On US television, the ads for Lipitor (atorvastatin, by Pfizer) featuring Dr Robert Jarvik are hard to avoid. In them, Dr Jarvik introduces himself as "Doctor," attests to the years has spent "studying the heart," attests to the value of Lipitor, which he takes himself, and is shown jogging, and apparently rowing a racing scull.

Concerns about these ads yhave now hit the big time. Stephanie Saul reported in the New York Times that not only, as we briefly mentioned, is Dr Jarvik "not a cardiologist and is not licensed to practice medicine," but that he does not know how to row. The images that seemed to be of Jarvik rowing the boat were combined from videos of a "body double," and of Dr Jarvik in a boat held fixed to a platform.

Why is this a serious matter? Pharmaceutical companies contend that they spend a great deal of effort "educating" physicians and the public. The NY Times article quoted a company email, "Pfizer stands behind its consumer advertising for Lipitor and our work with Dr. Jarvik to deliver important information on managing heart health."

Yet the deceptive elements of the advertising - Jarvik's identification as "doctor" implies he is a practicing physician, the body double in the scull implies Jarvik is especially vigorous and athletic - are the opposite of "important information."

Furthermore, the public may and should know Dr Jarvik as an innovative scientist and engineer(corroborated by Ms Saul's reporting that he is currently working on a miniaturized cardiac assist device for heart failure). As such, his words should be trusted. The public's trust is violated when he allows the words to be delivered in a deceptive context.

Finally, a separate report by ABC news alleged that Dr Jarvik received $1.35 million dollars for doing the advertisements. Obviously, that is a lot of money, and may have influenced Dr Jarvik to think and speak more favorably about Pfizer and Lipitor. The public's trust is further violated when someone who appears as a trusted scientist fails to disclose that he is being paid to deliver a pitch.

Maybe this high-profile case will lead to at least more honesty in direct-to-consumer health care advertising, and at least full disclosure by physicians and academics when they are paid by pharmaceutical/ biotechnology/ device/ etc companies to deliver "education." But physicians and academics ought to rethink whether it really fits their professional values to end up being viewed as salespeople employed by marketers.

NOTE - See also coverage by Ed Silverman in the PharmaLot blog, (also here) and on the WSJ Health Blog.

Post Title → Rowing Aground - More on Dr Jarvik's Misleading Advertisements

"Yee Hah" Direct to Consumer Advertising

An editorialist at The Day (New London, CT) had some choice comments about the current direct to consumer (DCT) advertising of Viagra (sildenafil), the erectile dysfunction (ED) drug made by Pfizer Inc.

Pfizer Inc. denies it, but it sure appears it no longer markets Viagra as simply medicine, but encourages recreational use by projecting an aphrodisiac-like image.

In 2005 Pfizer and other pharmaceutical companies peddling male impotence drugs toned down their advertising after the Food and Drug Administration criticized sexually-suggestive commercials that paid little attention to the medical problem the drugs are intended to address — erectile dysfunction (ED).

Pfizer, which had run TV advertisements of men growing blue devilish horns when the Viagra logo appeared, turned in late 2005 to conservative spots....

But the conservative strategy apparently produced impotent sales because Pfizer is back to using a 'yee-hah' approach to selling the little blue pill. New spots feature the catchy tune 'Viva Viagra,' sung in one commercial by a group of guitar-picking manly men who apparently share a desire not to disappoint their partners.
n another commercial a distinguished man twirls his date around the dance floor to the tune, before heading up the elevator with her for you know what. These advertisements frequently pop up when family members are watching a sporting event or movie. Talk about intrusive.

Last Christmas season a Viagra commercial aired during the reindeer movie
'Prancer.' A commercial for competitor Cialis appeared on an early-evening presentation of 'Miracle on 34th Street.' Happy holidays.

Dr. Brian Klee, senior medical director on the Pfizer Viagra global medical team, said the company has taken new steps to target the commercials for predominately adult audiences and avoid broadcasting them around religious and family holidays. He also said the marketing strategy is not intended to encourage men who don't really need the drug to give it a try, but instead to persuade men who do need it to work up the courage to ask their doctor about it.

Visit www.viagra.com/content on the web and you can see the 'real' Viva Viagra group singing.

Men visiting the site can then take a little quiz that basically leads to the conclusion that unless you're batting 1.000 in bed, you're a candidate for Viagra.

Apologies to Dr. Klee, but it appears clear the intent is to broaden the customer base for Viagra beyond men who are having real problems.

It is not spending that money because ED is a great medical scourge. It spends it to make money. Viagra sales totaled $836,436,000 for the company in 2007. It cannot achieve those kinds of sales figures without a lot of men asking for the blue pill, some who don't really need it. And with Pfizer profits falling 48 percent in the second quarter of this year, it needs sales.

Maybe there is nothing wrong with pushing Viagra this way. The drug has proved safe. It is the speciousness of Pfizer's approach that is maddening.

Having seen more than my fair share of Viagra (and Cialis) advertisements, often during nightly news programming, I share the editorialist's opinion that they are mainly about sex, not about erectile dysfunction.

Again, if pharmaceutical companies (and other health care organizations) were more honest about what they are doing, maybe they would no longer be regarded as "shifty."

Post Title → "Yee Hah" Direct to Consumer Advertising

BLOGSCAN - Even European Pharma Execs Don't Like DTC Advertising

On BrandweekNRX is a fascinating post on the disdain European pharmaceutical executives have for direct to patient (DCT) pharma advertising. On UK executive even said "that American drug advertising was regarded as so excessive in the UK that it had actually nixed the chances of UK drug companies being allowed to conduct similar promotions."

And the post started with a link to Question Authority with Dr Peter Rost which cited a commentary in a left-wing Swedish newspaper in which a Swedish Pfizer executive called DTC advertising "a bad model for Sweden."

So why do American pharma executives swear by DTC advertising? Are they dumber than their European counterparts, or are American consumers more gullible than European consumers?

Post Title → BLOGSCAN - Even European Pharma Execs Don't Like DTC Advertising

Educational DTC Drug Advertisements: "Minky Viagra Noni Noni Boo-Boo Plats"

We have posted before (most recently here) about the need to be very skeptical about direct-to-consumer (DTC) pharmaceutical advertising. On the other hand, DTC proponents often claim that the ads are valuable because they are educational. However, Alex Berenson just reported in the New York Times on television ads by Pfizer Inc for Viagra now being aired in Canada,

The ads feature middle-aged men and women talking in a made-up language, save for one word.

'Viagra spanglecheff?' says a man to a friend at a bowling alley.

'Spanglecheff?' his friend asks.

'Minky Viagra noni noni boo-boo plats!' the first man replies, with a grin that suggests he is not talking about the drug’s side effects. The ads end with the slogan, 'The International Language of Viagra.'

I cannot wait to hear from Pfizer how complete gibberish is educational. But maybe to a drug marketer, it is.

Post Title → Educational DTC Drug Advertisements: "Minky Viagra Noni Noni Boo-Boo Plats"

The Butterfly Runs Into Flak: Critically Analyzing Lunesta's Television Ad

National Public Radio's show "All Things Considered" ran a segment last week explaining how direct to consumer (DTC) advertising can make drugs appear better than they may really be.

The show focused on a single television advertisement (with the butterfly) for Lunesta (eszopiclone) marketed by Sepracor for insomnia. The show focused first on the psychology of advertising design, pointing out the following features:

Using Images to "Sell You a Feeling" - The advertisement shows a lovely woman waking up after an apparently restful sleep produced by Lunesta. A former TV producer commented, "and when she wakes up, she's just gorgeous. She sits right up and stretches and looks great. Who wouldn't want that?" Thus, "you remember what you feel longer than what you know." So the image of restful sleep swamps all those facts about adverse effects presented later.

Obscuring the Adverse Effects - A number of tactics are used to make it less likely that the viewer will remember the obligatory recitation of adverse effects. These include

• Putting the litany in the middle of the advertisement, since it is hardest to remember the middle of a presentation.
• Reciting facts quickly, and using a more advanced vocabulary than the rest of the advertisement.
• Presenting the visual images during the recitation that do not correspond to the words spoken, so "when the eye and the ear compete, the eye wins."

The show also featured an analysis by Dr Lisa Schwartz of the claims made in the ad versus a critical reading of the most relevant evidence from clinical research (that is, using the evidence-based medicine approach). Her main points were about how the advertisement:

• Enlarges the Eligible Population - The ad suggests that the drug is suitable for "millions of Americans who once had trouble turning off their restless minds," that is, a large population of people who have occasional trouble falling asleep. But clinical studies of the drug were limited to defined populations of people who fit the DSM-IV criteria for insomnia, and who reported sleeping less than 6.5 hours a night, and taking >30 minutes to fall asleep for at least a month. Thus the ad appears to be trying to expand the population of patients for whom the drug is marketed well beyond those patients who were in the clinical trials of the drug.
• Exaggerates Results About Amount of Sleep - The ad suggests that people can sleep all through the night on Lunesta, implying that it leads to eight hours of sleep. Schwartz noted that the largest trial of Lunesta [Krystal AD, Walsh JK, Laska E et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep 2003; 26: 793-799.] only showed that patients given Lunesta slept 37 minutes longer, for an average of 6 hours and 22 minutes, than those given placebo. Thus, Lunesta did not prolong sleep much longer than placebo, and did not on average result in anything close to 8 hours of sleep.
• Exaggerates Results About Falling Asleep- The ad suggests Lunesta "works quickly." Yet the study results suggest that those taking Lunesta fell asleep only 15 minutes earlier than those taking placebo.
• Exaggerates Long-Term Usability - The ad suggests that the drug "is approved for long-term use." Yet the longest study of the drug only lasted six months, not what many people would call long-term.

Note that Sepracor said it based the advertising claims on a different smaller, shorter study that assessed patients in a sleep lab. [McCall WV, Erman M, Krystal AD et al. A polysomnographyt study of eszopiclone in elderly patients with insomnia. Curr Med Research Opinion 2006; 22: 1633-1642.] Yet this study only lasted 2 weeks, and it excluded patients with many chronic problems such as sleep apnea, chronic obstructive pulmonary disease, "uncontrolled medical abnormalities or unstable chronic disease, medical or psychiatric disorders," etc. Even so, this study only showed that people feel asleep on average of 11 minutes faster on Lunesta (average sleep latency -40.8 vs -29.6), and slept only 16.2 minutes longer (average change of total sleep time 48.6 vs 32.4 minutes).

The main points are that DTC advertising, rather than being educational, may be psychologically designed to convey positive impressions about the product far beyond the actual words used. Furthermore, the words used are still likely to suggest that the product is much better than what the data from clinical research suggest. In this case, rather than being a wonder drug, Lunesta on average makes people fall asleep a few minutes earlier and sleep a few minutes longer than they would have without it. These small advantages should be weighed against its adverse effects, including strange sleep behaviors which the FDA wants to add to Lunesta's (and other "sleep aids'") labels but which were apparently not in the advertisement.

Patients should be extremely skeptical about DTC advertising, especially about whether the psychological good feelings conveyed by the ads obscure the cold facts about the drug, and whether the facts spoken about the drug exaggerate its benefits and obscure its harms.

Knowing about these issues, physicians need to be appropriately circumspect when patients ask for that wonder drug they saw on TV. Remember that DTC ads are particularly likely to amount to pseudoevidence-based medicine.

Post Title → The Butterfly Runs Into Flak: Critically Analyzing Lunesta's Television Ad

Medtronic Marketers Try to Sell Implantable Cardiac Defibrillators Direct to Patients

The latest subject of direct to consumer (DTC) advertising is medical devices. The Minneapolis Star-Tribune reports,

Medical technology giant Medtronic Inc. will launch a $100 million marketing campaign today to raise awareness about the dangers of sudden cardiac arrest -- and the role of heart defibrillators in saving lives.

Fridley-based Medtronic said the 'What's Inside' sudden cardiac arrest ad campaign is part of a bigger awareness push that is the largest in size and scope in company history.

'This is about saving lives,' said Dr. David Steinhaus, vice president and medical director of Medtronic's Cardiac Rhythm Disease Management division. 'Sudden cardiac arrest kills more people than breast cancer, lung cancer and HIV/AIDS combined.'

Sudden cardiac arrest can be prevented with a device called an implantable cardioverter defibrillator (ICD) -- a stopwatch-sized device implanted in the chest that shocks an errantly beating heart back into rhythm. But a series of safety recalls by manufacturers in 2005 -- including market leader Medtronic -- dampened demand for the device in the past year

Part of the problem is that patients who need the devices aren't necessarily getting them -- Medtronic estimates roughly 850,000 Americans are in this category.
Sometimes prospective patients don't have symptoms, which can make it difficult for doctors to persuade them to undergo an ICD implant procedure, Medtronic's Steinhaus said.

In addition, sometimes patients are not referred to the appropriate specialists (called electrophysiologists) who implant the devices -- which is why Medtronic is also targeting the general cardiology community with physician education programs, he said.

Sorry, but to me, this one smells bad from the get go.

The kicker here is the populations of patients for whom ICDs might be indicated. The notion that there are patients who ought to have ICDs implanted, but are walking around, without any symptoms, in blissful ignorance of this fact does not make a lot of sense to me.

Right now, there are two groups of patients for whom ICDs might have benefits that outweigh their harms. The first are patients who have already had a "near sudden death" experience, i.e., patients who have dropped their blood pressure, or fainted (had syncope) due to a particularly dangerous kind of rapid heart beat (ventricular tachycardia). To have had such diagnoses, such patients, have had to already come to medical attention. They do not need advertising campaigns to tell them they ought to have an ICD. [For a discussion of this group, see Josephson ME et al. The role of the implantable cardioverter-defibrillator for prevention of sudden cardiac death. Ann Intern Med 2000; 133: 901-910.]

The second group are patients at very high risk of such deranged heart rhythms. The MADIT II Trial suggested that patients who have had a heart attack (myocardial infarction) and have poor heart function (left ventricular ejection fraction less than 30%) have increased survival after placement of an ICD. [Moss AJ et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877-883.] The SCD-HeFT trial suggested that patients with congestive heart failure who are moderately symptomatic (New York Heart Association classes II and III) and have a ventricular ejection fraction of less than 35% may also so benefit. [Gardy GH et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352: 225-237.] Again, most people who have had myocardial infarction resulting in poor heart function are not walking around blissfully unaware of these major problems, nor are people with at least moderately symptomatic heart failure.

Furthermore, there are many legitimate reasons that people who fit into the categories listed above should not have ICDs. In particular, many people with such serious heart disease also have other severe medical problems. The benefits versus harms of ICDs is unknown in such patients, who would have been excluded from the trials above. (For example, MADIT II excluded anyone with another severe disease that increased the risk of death during the trial time-frame.) Patients with other severe medical problems could die or become seriously ill from these other problems before having any opportunity for an ICD to prevent a dangerous rhythm disturbance.

So I question the whole notion that the DTC advertising would flush out tens of thousands of patients who were totally unaware that they could benefit from ICD placement.

So why do this advertising campaign? Is it just a result of how marketers have come to dominate nearly every health care organization, including device manufacturers? Many of those of the marketing persuasion seem to be totally focused on selling more product. That may be good for the marketers' careers, but it may not be good for those having these particular products implanted in their chests.

In health care, our goal should be first only to do things to patients whose benefits are likely to outweigh their harms, not just to move expensive products off the shelves.

Hat tips to the Over My Med Body blog and the Schwitzer Health News Blog.

Please also see the comments on SurgeonsBlog, on having one's mind blown by one of the print advertisements from this campaign in the New York Times.

Post Title → Medtronic Marketers Try to Sell Implantable Cardiac Defibrillators Direct to Patients

Advertisers Want to Strip Direct to Consumer Drug Advertisements of Specific Information on Side Effects

The Associated Press reported that the Coalition for Healthcare Communication submitted a petition to the US Food and Drug Administration (FDA) to abolish the requirement that direct to consumer advertising of drugs include information about their specific adverse reactions. Instead, the Coalition suggested that the advertisements "simply carry a boilerplate warning that all perscription drugs have potential risks and benefits." (See an early post on direct to consumer advertising here.) "The Coalition for Healthcare Communication's members include the American Association of Advertising Agencies, Healthcare Marketing and Communications Council and Public Relations Society of America."

Their rationale was, "While some may think it desirable to tell consumers about all side effects and contraindications, no matter how clearly this information is communicated to consumers, a significant number will lack the education or background to comprehend or act on it." [emphasis added]

Of course, this raises the question of whether direct to consumer advertising, which is apparently only allowed in the US and New Zealand, is a good idea at all. Should patients who may not be able to comprehend information about drugs' adverse effects be exposed to sometimes emotionally based advertising designed to promote drugs' supposed benefits?

Post Title → Advertisers Want to Strip Direct to Consumer Drug Advertisements of Specific Information on Side Effects

Advertised Explanations of How SSRI Anti-Depressants Work May Be Misleading

A new commentary in PLoS Medicine (full citation: Lacasse JR, Leo J (2005) Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature. PLoS Med 2(12): e392 ) suggests that direct-to-consumer advertisement (DTCA) of the newer selective serotonin reuptake inhibitor (SSRI) medications for depression and anxiety may be misleading.
In particular, such advertisements sometimes suggest that these drugs correct an imbalance of serotonin chemistry in the brain. For example, the article quoted these advertisements:

• “Celexa helps to restore the brain’s chemical balance by increasing the supply of a chemical messenger in the brain called serotonin."
• “When you’re clinically depressed, one thing that can happen is the level of serotonin (a chemical in your body) may drop. So you may have trouble sleeping. Feel unusually sad or irritable. Find it hard to concentrate. Lose your appetite. Lack energy. Or have trouble feeling pleasure…to help bring serotonin levels closer to normal, the medicine doctors now prescribe most often is Prozac®”
• “Chronic anxiety can be overwhelming. But it can also be overcome…Paxil, the most prescribed medication of its kind for generalized anxiety, works to correct the chemical imbalance believed to cause the disorder."
• “While the cause is unknown, depression may be related to an imbalance of natural chemicals between nerve cells in the brain. Prescription Zoloft works to correct this imbalance. You just shouldn’t have to feel this way anymore”

Providing such a physiologic explanation for these drugs' actions makes it more plausible that they benefit patients.
Yet the theory that depression or anxiety are due to imbalances in brain levels of serotonin is just that. There is no proof that it is correct, and in my humble opinion, it seems overly simplistic given our increasing but still fragmentary understanding of neuroscience. Thus the advertisements may be misleading because they provide seemingly authoritative mechanistic explanations of why these drugs should work that are not necessarily true.
Again, neither patients nor doctors are served well by potentially misleading marketing, especially when there are new questions whether the class of drugs being marketed is really superior to older (and cheaper) alternatives.
Thanks to Schwitzer's Health News blog for the tip.

Post Title → Advertised Explanations of How SSRI Anti-Depressants Work May Be Misleading

Celebrities More Often Pitching "Disease Awareness"

The Associated Press reported on the increasing frequency of "disease awareness" advertising featuring celebrities. Examples included Cheryl Ladd talking about menopausal symptoms (for Wyeth, makers of Prempro and Premarin), and Lance Armstrong talking about cancer (for Bristol-Myers-Squibb, makers of various chemotherapeutic agents). Important older examples include Dorothy Hamill and Bruce Jenner talking about arthritis (for Merck, maker of Vioxx, now off the market) and, of course, Bob Dole talking about erectile dysfunction (for Pfizer, maker of Viagra). The article suggests that pharmaceutical companies will be increasingly turning to disease awareness campaigns, since such advertisements do not necessarily mention specific drugs, and hence do not have to discuss adverse effects.
The article noted that celebrities may make from $200,000 to $1 million for such advertisements, and that their work is facilitated by several agencies that specialize in connecting them to health care companies.
I was surprised that Thomas Abrams, head of the US Food and Drug Administration (FDA) division of marketing, advertising, and communication, endorsed such advertisements, "we think disease awareness commercials are very beneficial. There's a number of diseases in the United States ... which can have devastating effects of they go untreated." Based on the examples above, it appears his definition of "devastating effects" may be a bit broad.
Again, it appears that some pharmaceutical companies are eager to entice patients with emotional appeals made by popular public figures skilled in communicating, but hardly expert in medicine. There won't be any extra support, however, for physicians who will have to balance their patients' new "disease awareness" with the risks and costs of the drug manufacturers' latest products.

Post Title → Celebrities More Often Pitching "Disease Awareness"

MedRants Blogger's Op-Ed Against Direct to Consumer Drug Advertising

Fellow health care blogger Robert Centor MD (of MedRants) published an op-ed in USA Today advocating that direct to consumer (DTC) advertisements for pharmaceuticals should be banned.
I do worry that DTC ads push people to get drugs for mild conditions, for which the drugs' benefits may not outweigh their harms, and push people to get expensive name-brand drugs when cheaper generic drugs may work just as well. (Many people with indigestion or GERD will do just as well with the little purple pill than with a generic or over-the-counter H2 blocker, or even simple antacids.)
I am also concerned that banning DTC ads does infringe on free speech. But as I have said before, I wonder why there has been no organized effort to develop counter-advertising, especially by government agencies and managed care organizations who proclaim their interests in cutting costs and improving health care?

Post Title → MedRants Blogger's Op-Ed Against Direct to Consumer Drug Advertising

Media Reports on How Pharmaceutical Companies May Manipulate Information

Newspapers have become interested, again, in the issue of pharmaceutical companies manipulating information supplied to the public or health care professionals.

USA Today published several stories on the pharmaceutical industry. One was on various tactics the industry may used to mislead the public in television direct to consumer advertising, according to the US Food and Drug Administration (FDA). These included:

• Overstating the effectiveness of a drug. For example, a Novartis ad included graphics that implied, according to the FDA, Lamisil is completely effective in eradicating nail fungus. The FDA asserted, in contrast, that clinical trials only revealed a 38% cure rate.
• Advertising a drug for problems other than those for which its use was approved by the FDA. For example, Wyeth advertised Effexor as treatment of mild depressive symptoms, according to the FDA. The drug, however, was only approved by the FDA for major depressive disorder.
• Unsubstantiated claims. For example, Hoffman-La Roche advertised Xeloda, a cancer chemotherapy agent, using testimonials that the drug didn't make patients "too tired" or "too sick." However, the FDA noted "in stark contrast" the number of reports that Xeloda makes people feel sick and tired.

USA Today also ran a story on how pharmaceutical companies may ghost-write articles, and then try to get academics to pose as first authors. (Our last posting on ghost-writing is here, and a posting about how medical schools are willing to sign contracts with research sponsors that allow the sponsors to write up research results, is here.) It included an estimate by Dr. Martha Gerrity, Co-Editor of the Journal of General Internal Medicine, that two to four of the 70-80 manuscripts the journal receives each month may be ghost-written. Dr. Catherine DeAngelis, the Editor of the Journal of the American Medical Association said that before she became an editor, she got one phone call a month asking her to pose as the author of a ghost-written article. The article provides another bit of evidence that ghost-writing may be far more prevalent than most physicians and researchers realized. Yet, as Dr. DeAngelis said, ghost-writing is "manipulation by for-profits to alter what's in the (medical) literature so that they could sell their products."
Finally, the NY Times ran a story suggesting that pharmaceutical companies seem split about whether to submit information to online registries of controlled trials. These registries had been proposed as a way to prevent the companies from hiding unfavorable results of clinical trials.
Some companies, notably Eli Lilly, have apparently been quick to provide trial information to the registries. Dr. Alan Breier, the company's chief medical officer, said "fundamentally, what we're doing is in the interest of patients, and I think that this is the winning model, for academia, for industry, and the future."
On the other hand, some companies, e.g., Merck, Pfizer, and GlaxoSmithKline, have been stingy in the information they have provided to the NIH clinical trials registry, clinicaltrials.gov. Dr. Deborah Zarin, the director of the site, noted, for example, that Merck only said that one trial was a "one-year stury of an investigational drug in obese patients." Failing to provide crucial details, like the name of the drug, would make it impossible in the future to tell if Merck ever published a report of the trial's results.
The Times reported that "executives and press representatives at the companies said generally that disclosing too much information about early-state trials might reveal business or scientfic secrets." On the other hand, Dr. Breir of Lilly felt that it could supply information to the registry while still protecting its intellectual property.
In summary, physicians' efforts to make decisions for patients based on the best available research data are frustrated when companies hide or manipulate research results which put their products in a bad light. Manipulating or hiding research results betrays those patients who volunteered to participate in clinical trials intending to help advance science and improve patient care. Misleading advertising pushes patients to get treatments that are needlessly expensive, and sometimes needlessly hazardous. Too often, pharmaceutical companies seem to have forgotten their high-minded promises to help patients with better treatments in the pursuit of short-term profits.

Post Title → Media Reports on How Pharmaceutical Companies May Manipulate Information

FDA Scolds Drug Companies for Direct to Consumer Advertising

In the Boston Globe, a US Food and Drug Admininstration (FDA) official scolded drug companies for their direct to consumer (DTC) advertising, saying "consider this a heads up. We are very concerned about the direction consumer advertising seems to be taking."
It took them long enough to become concerned.
However, I wonder whether the drug companies will submit voluntarily to more stringent regulation of DTC advertising, or will they argue that it's a violation of their free speech rights. And if they made such an argument, they might be right.
But as something of a free speech absolutist, I believe that the best way to challenge speech with which you disagree is by speaking out against it, not by attempting to silence it.
So I continue to wonder why all those "concerned" about DTC advertising, which ought to include managed care organizations and us physicians as well as the FDA, don't try to communicate directly to the public to counter the DTC advertising with which they disagree.

Post Title → FDA Scolds Drug Companies for Direct to Consumer Advertising

Vested Interests in Direct-to-Consumer Drug Advertising

As a physician, my blood pressure goes up every time I see the ad about the little purple pill, or the ad involving the guy throwing the football through the old tire (but which is not about throwing, or footballs, or tires), etc., etc., etc. I am convinced that such advertisements provide almost no education to patients. But they probably persuade quite a few to pressure their physicians for drugs that they may not really need, or that may not be the best choices for them. Promoting little purple pills shoves aside the complex balancing of benefits, harms, and costs that should underly choice of therapeutic agents. For how many patients with dyspepsia or GERD will that little purple pill really work better than a generic H2-blocker or proton pump inhibitor?
What has made the current news about the Cox-2 inhibitors so troubling is that the drugs were advertised heavily as generally useful for arthritis, and all sorts of aches and pains. Thus, many patients for whom the drugs provided no particular advantage were exposed to their risks of adverse effects. Will the lessons learned from this episode lead to decreased, and/or more informative and realistic direct-to-consumer drug advertising?
The NY Times today reported the extent of vested interests in keeping such direct-to-consumer advertising going. Merck's spending on advertising Vioxx was $78 million a year. Pfizer was planning to spend more than $87.6 million on advertising Celebrex this year until it canceled the campaign. $3.8 million is now spent yearly on all direct-to-consumer drug advertising. This is not a trivial business for advertising agencies. Furthermore, $110 million, about one-third of the advertising revenue of the big three network evening news programs, comes from direct-to-consumer drug advertising. It remains to be seen whether such vested interests will resist down-sizing direct to consumer advertising, or at least making it more realistic and less like "marketing for Cheerios."

Post Title → Vested Interests in Direct-to-Consumer Drug Advertising